Sunstone Therapies Clinical Research Coordinator Rockville, MD · Full time

The Clinical Research Coordinator (CRC) will conduct clinical trials using good clinical practice under the auspices of a Principal Investigator (PI). This includes planning and management of research studies, enrollment, and maintaining compliance with federal, state, and institutional regulations.

Description

To be successful in this role in this growth stage start-up, the candidate must be a detail-oriented self-starter and problem solver, be able to shift projects and priorities rapidly to meet emerging needs, and approach the work with the values of love and rigor, which are essential to the Sunstone culture.  


Clinical Research Coordinator Responsibilities:

  • Overseeing the smooth running of clinical trials.
  • Collecting data obtained from research according to good clinical practice standards and meet ALCOA standards of data quality and integrity.
  • Managing research budgets.
  • Informing participants about study objectives.
  • Administering questionnaires.
  • Monitoring research participants to ensure adherence to study rules.
  • Adhering to research regulatory standards.
  • Adhering to ethical standards.
  • Maintaining detailed records of studies as per FDA guidelines.
  • Liaising with laboratories regarding findings.
  • Participating in subject recruitment efforts.
  • Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
  • Engaging with subjects and understanding their concerns.
  • Engaging with investigators on clinical trials to ensure regulatory requirements are met, plan study execution to optimize the experience of all participants, organize and plan study execution to maximize operational and financial efficiencies.
  • Educating investigators on the operational details of clinical trials.

Background and job requirements:

  • 1 – 3 years related experience, with a preference for research in private practice setting.
  • 4-year degree in a related field is strongly preferred.
  • CRC certification preferred.
  • May have periods of hybrid work, however, must be available to be in person in Rockville to support clinical trials.

Preferred Capabilities

  • Analytical mindset.
  • Attention to detail.
  • Exceptional interpersonal skills.
  • Outstanding written and verbal communication.
  • Excellent organizational skills.
  • A self-starter with a willingness to continually self-educate.